This week I am posting one of my favorite essays from last fall because at this moment, I am in the middle of moving my home and office from one side of the Chicago metro area to the other to be closer to our kids. Also at this moment, the FDA is almost eight months late in publishing the grandfathering guidance that was mandated by the DSCSA. Here it is again.
One of the surprising things about industry preparations for the Drug Supply Chain Security Act (DSCSA) is how hard it is to make label changes to add the new DSCSA product identifier barcode (see “The DSCSA Product Identifier On Drug Packages”). The artwork changes necessary take a lot longer than everyone originally expected. Companies with hundreds of different drug packages to redesign may have trouble getting all the work done by the November 27, 2017 deadline (2018 for repackagers). If you have thousands of different packages, you had better have a large team working on the artwork changes right now.
A few months ago the FDA opened two “dockets”, or Requests for Comments (RFC) to collect ideas and experiences about technology pilots related to the Drug Supply Chain Security Act (DSCSA). The first docket was associated with the FDA Public Meeting held on April 5 and 6 (see “The 2016 FDA Pilots Workshop”). The second docket was opened shortly after the Public Meeting to continue collecting the same kind of information from anyone who had already conducted their own pilots or was planning future pilots. Both dockets are now closed so here is a look at the responses. Continue reading HDMA Responds To FDA Pilots RFC→
Medical convenience kits are exempt from the Drug Supply Chain Security Act (DSCSA). But be careful. Just because you and your customers have called your product “a kit” for years doesn’t mean that Congress and the FDA call it that under the DSCSA. In fact, many products that have historically been referred to as “medical convenience kits” will be treated under the DSCSA as a repackaged drug, a combination product, or worse, just a collection of device(s) and drug(s). Let’s take a closer look. Continue reading DSCSA: Kit, Repack, Combo Product, or Just A ‘Collection’?→
RxTrace followers will want to register and listen in on the Healthcare Distribution Management Association’s (HDMA) upcoming important webinar on May 19, 2016 from 1:00 to 2:00pm EDT. The webinar will cover the new changes to their “Bar Coding Quick Start Guide” for compliance with the U.S. Drug Supply Chain Security Act. HDMA originally published this document back in 2014 (see the HDMA’s website) but they are expected to publish an updated version of it any day now. I checked the HDMA website last night and did not see the new version, but with the scheduling of this webinar, odds are it will be made available to the public between now and May 19.
DISCLAIMER: RxTrace contains some of the personal thoughts, ideas and opinions of Dirk Rodgers. The material contained in RxTrace is not legal advice. Dirk Rodgers is not a lawyer. The reader must make their own decisions about the accuracy of the opinions expressed in RxTrace. Readers are encouraged to consult their own legal counsel and trading partners before taking any actions based on information found in RxTrace. RxTrace is not a vehicle for communicating the positions of any company, organization or individual other than Dirk Rodgers.